ImpediMed Limited: FDA filings under this applicant name

FDA lists 13 510(k) clearances under the applicant name “ImpediMed Limited” (first 2011, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 121 days. Since 2017 the median was 121 days, against 166 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name ImpediMed Limited took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.

Top product codes

Review panels

• Gastroenterology and Urology (8)
• Cardiovascular (5)

Most recent ImpediMed Limited 510(k) clearances

3 earlier clearances. See the full list in Caduvo.

Recalls

1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-08-17.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named ImpediMed Limited is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT02939053: Correlation of SOZO BIS Measures With CardioMEMS PA Pressure (Completed, started 2017-08-29)
• NCT02167659: Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT) (Completed, started 2014-06)
• NCT00766935: The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device (Completed, started 2007-11)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Impedimed Pty , Ltd. (4 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under ImpediMed Limited?

FDA lists 13 510(k) clearances under the applicant name “ImpediMed Limited” (first 2011, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by ImpediMed Limited?

The median time from FDA receipt to decision across 510(k)s cleared under the name ImpediMed Limited is 121 days. Since 2017: 121 days, versus 166 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under ImpediMed Limited?

The most frequent FDA product codes under this applicant name are OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity, 6); DSB (Plethysmograph, Impedance, 5); QJB (Adjunct Monitor, Protein Calorie Malnutrition, 2).

Next steps

• See all 13 ImpediMed Limited clearances with predicates and recalls
• Run predicate analysis for product code OBH, ImpediMed Limited's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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